After Winning FDA Approval for Actos’ Active Ingredient Alogliptin, Takeda Will Offer Three New Drugs
After much back and forth with the FDA, Takeda Pharmaceuticals – the manufacturers of the controversial and dangerous Type 2 diabetes drug, Actos – have won approval for new formulations of the active ingredient alogliptin.
Actos, the best-selling but much-maligned Type 2 diabetes drug, lost patent protection in August 2012. Afterwards, there was a rush for FDA approval of the generic version, pioglitazone, which will shortly be released onto the US market.
Sales of Actos peaked in March 2011, at $4.5 billion – 27% of Takeda Pharmaceutical’s revenue.
It is no surprise, then, that the company is now pushing to release new brand-name versions of their drug, despite personal injury lawsuits claiming that the formula can cause bladder cancer and other dangerous side effects.
Takeda Pharmaceuticals Faces Thousands of Personal Injury Lawsuits Due to Actos
In October 2012, the one-thousandth lawsuit against Takeda Pharmaceuticals for an Actos-related death was added to the multidistrict litigation (MDL) in Louisiana, with the Honorable Judge Rebecca Doherty presiding. The two most recent lawsuits, from the Person and Astorga families, allege that Actos is an “unreasonably dangerous and defective drug,” and that Takeda Pharmaceuticals acted with “willful and malicious negligence.” Many plaintiffs, including these two families, allege that the manufacturer knew in advance of the dangers based on statistical evidence from lab tests, but concealed the knowledge and failed to warn the FDA, doctors, and patients of the real risks of taking the drug.
Actos, however, has a long history of legal and scientific problems. A study released in 2011, that strongly linked Actos to bladder cancer in patients who took the drug for two or more years, led both France and Germany to completely ban the drug from their markets.
Despite public outcry, and the multidistrict litigation, the FDA has not formally recognized that Actos, and chemically-similar drugs including generics, could cause bladder cancer. In fact, the FDA said on January 25th that “Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control.”
Delays in Winning FDA Approval for Actos-Like Drugs
Although the FDA has been heavily criticized for its acceptance of pioglitazone and alogliptin – two of the controversial chemicals in Actos – the government agency did insist on a longer testing period for Takeda Pharmaceuticals, denying approval of alogliptin twice.
The FDA first rejected Takeda’s approval request in 2009, when concerns about cardiovascular problems, especially related to another Type 2 diabetes drug Avandia, ran high. The FDA said that clinical data submitted by Takeda in 2008 was insufficient to prove the drug’s safety. Takeda conducted more studies and submitted more clinical data last April, but the FDA again denied the application because the drug’s safety was still in question – this time, because of strong ties to bladder cancer.
Now that the FDA has approved alogliptin-based drugs for the US market, doctors and patients should be wary of harmful side effects, especially bladder cancer. Takeda Pharmaceuticals will release its most popular alogliptin drug, Nesina, to the market soon – the drug has been used worldwide, except in the US. Takeda will also make Oseni and Kazano, two other alogliptin drugs, available.
The Strom Law Firm Handles Personal Injury Cases Against Actos
Evidence strongly links Actos to increased risk of bladder cancer, but the drug also has other dangerous side effects. If you or a loved one take Actos or the generic, pioglitazone, to treat Type 2 diabetes, and have since developed bladder cancer, heart disease, liver failure, or diabetic macular edema, you may be entitled to compensation.
The lawsuits are consolidated into one multidistrict litigation, MDL 2299, with the Hon. Rebecca Doherty presiding. If you have your own concerns about Actos and side effects that have developed while you took the drug, the Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800.